Expert Analysis

• New Orphan Drug Law Provides A Key Fix For Pharma Cos.

  

  The Consolidated Appropriations Act enacted last month restores the U.S. Food and Drug Administration's long-standing interpretation of "same disease or condition," related to orphan drug exclusivity, resolving years of regulatory uncertainty and litigation that have discouraged rare disease research, say attorneys at Spencer Fane.

• Stablecoin Yield Reform Raises Stakes For Community Banks

  

  Risks for community banks are heightened by the Clarity and Genius Acts, which establish stablecoin market parameters and may lead to traditional bank fund withdrawals in the long term, but a recent Senate amendment to the former bill could prevent deposit runoff, says Thomas Walker at Jones Walker.

• How Iran War Might Reshape Proxy Contests This Year

  

  The Iran war may function as a short-term poison pill for proxy contests, not because it strengthens corporate defenses, but because it increases the risks associated with activist commitments, say attorneys at Sidley.

• Opinion

  PTAB Needs Reform To Protect Inventors From Larger Cos.

  

  The Promoting and Respecting Economically Vital American Innovation Leadership Act is necessary because it will impose additional requirements on patent validity challenges and prevent large corporations from taking advantage of the Patent Trial and Appeal Board to overwhelm small inventors with repeated litigation, says Eb Bright at ExploraMed Development.

• What To Watch At The 2026 ABA Antitrust Spring Meeting

  

  Attorneys at Freshfields consider the future of antitrust law and competition among developments likely to dominate discussion at the American Bar Association's Antitrust Spring Meeting this week.

• FDA User Fee Talks Offer Clues On Upcoming Reforms

  

  As the U.S. Food and Drug Administration undergoes the User Fee Act reauthorization process and renegotiates its user fee agreements over the next several months, the agency's consultation meetings with relevant industries can shed light on the FDA's priorities, and provides stakeholders an opportunity to participate in the reform process, say attorneys at Holland & Knight.

• Changes Coming To The SBIR And STTR Programs

  

  Legislation recently approved by Congress to reauthorize the Small Business Innovation Research and Small Business Technology Transfer Programs includes changes focused on national security that would improve transparency but also increase applicants' administrative burdens, slow the awards process and likely increase litigation, say attorneys at Fluet & Associates.

• What FINRA Enforcement Changes Mean For Investigations

  

  It is essential for in-house counsel and compliance officers to familiarize themselves with the Financial Industry Regulatory Authority's recently announced changes to its enforcement program, which offer both clearer visibility into FINRA's expectations and a valuable opportunity to strengthen regulatory readiness, say attorneys at Eversheds Sutherland.

• One Idea To Fix The SEC's Risk Factor Disclosure Rules

  

  U.S. Securities and Exchange Commission Chairman Paul Atkins recently invited the industry to suggest ways to reform the current risk factor disclosure framework, and amending Rule 10b-5 is one potential option to consider, say attorneys at A&O Shearman.

• Navigating Venezuelan Oil And Gas Sanctions Rollbacks

  

  The U.S. Department of the Treasury's Office of Foreign Assets Control has issued a series of general licenses representing the broadest easing of Venezuela-related sanctions in years, and creating significant new opportunities — but only for entities prepared to meet the rigorous conditions attached to OFAC's phased sanctions relief, say attorneys at Winston & Strawn.

• 7 Employer Tips For Handling Calif. Privacy Risk Assessments

  

  Recent changes to the California Consumer Privacy Act require certain employers to complete detailed risk assessments before handling workforce data in many routine ways, so employers should assess whether previous risk assessments can be reused or combined, assemble a team, and create a plan of action, among other steps, say attorneys at Littler.

• Breaking Down State Legislative Efforts In Telecom Security

  

  As the federal government has strengthened national security safeguards for the telecommunications ecosystem, states have also asserted a role in telecom security, with variations among these regimes risking regulatory fragmentation and complicating compliance strategies, say attorneys at Hogan Lovells.

• Agentic AI Use May Trigger Existing Consumer Finance Laws

  

  As artificial intelligence agents interact more and more with payment systems, financial institutions should be cognizant of how existing consumer protection laws like the Equal Credit Opportunity Act apply when transactions are executed by automated systems rather than individuals, noting authorization and liability gaps, say attorneys at Sheppard.

• SEC Guidance Further Solidifies Status Of Tokenized Assets

  

  The U.S. Securities and Exchange Commission recently released a statement that tokenized securities are securities governed by traditional securities laws, representing continued regulatory clarity and the development of expanded technical standards and risk management guidelines that can only improve the long-term viability of financial markets, say attorneys at Barnes & Thornburg.

• FDA Framework For Personalized Therapies Raises Questions

  

  The U.S. Food and Drug Administration's new plausible mechanism framework for developing individualized therapies reflects the agency's focus on rare-disease drugs, but numerous significant, unresolved issues cast uncertainty on how effective the framework will be in practice, say attorneys at Ropes & Gray.